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Monthly MK-8527 to prevent HIV-1 infection

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

PHASE3 · Merck Sharp & Dohme LLC · NCT07044297

This trial will test whether a once-a-month MK-8527 regimen can prevent HIV-1 infection as well as or better than daily oral FTC/TDF in people at risk.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment4390 (estimated)
Ages16 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Locations81 sites (Birmingham, Alabama and 80 other locations)
Trial IDNCT07044297 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, double-dummy trial compares monthly MK-8527 with daily oral FTC/TDF for HIV pre-exposure prophylaxis in HIV-uninfected adults at risk through receptive anal sex. Participants are randomized to receive either monthly MK-8527 injections plus daily oral placebo, or monthly placebo injections plus daily FTC/TDF, with regular HIV testing and safety monitoring. The study tracks new HIV-1 infections and adverse events to determine whether monthly MK-8527 is noninferior or superior to standard daily PrEP. Enrollment focuses on cisgender men, transgender women, transgender men, and nonbinary people reporting condomless receptive anal sex and other recent risk factors.

Who should consider this trial

Good fit: Ideal candidates are HIV-negative adults who are cisgender men, transgender women, transgender men, or nonbinary people with recent condomless receptive anal sex and at least one additional risk factor such as multiple partners, recent STI, or stimulant use with sex.

Not a fit: People already living with HIV or those with contraindications or hypersensitivity to any study medication are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, monthly MK-8527 could offer an effective, less frequent alternative to daily oral PrEP, improving adherence and protection for people at risk of HIV-1.

How similar studies have performed: Similar long-acting injectable PrEP approaches (for example cabotegravir LA) have shown strong effectiveness compared with daily FTC/TDF, making this monthly approach promising but still needing confirmation for MK-8527.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
* Weighs ≥35 kg

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has hypersensitivity or other contraindication to any component of the study interventions
* Has evidence of acute or chronic hepatitis B infection
* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
* Is expecting to donate eggs at any time during the study

Where this trial is running

Birmingham, Alabama and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Human Immunodeficiency Virus, HIV Pre-Exposure Prophylaxis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.